PsychosisNCT06408740
Physical Activity Level in Psychosis Patients
An observational study of Psychosis, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to examine the effect of physical activity level on social participation, functioning and quality of life in patients with psychosis. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Psychosis
- How many people
- 157 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2023to 20 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Psychosis patients
Who may be able to join
- Patients diagnosed with schizophrenia and other psychotic disorders according to DSM-V criteria (brief psychosis disorder, schizophreniform disorder, schizoaffective disorder, other disorder with psychosis within the scope of another defined schizophrenia and other disorders with psychosis, other disorders with psychosis within the scope of undefined schizophrenia and other disorders with psychosis), who have had their first episode, who are receiving outpatient treatment
- Whose duration of illness is longer than 2 years
- Being between the ages of 18-65
- Being literate
Who cannot join
- The participant is in a period of active illness that makes it difficult to conduct research (Positive and Negative Syndrome Scale>70 scale points, Calgary Depression in Schizophrenia Scale score >11 scale points)
- Comorbid psychiatric illness
- The patient has an acute or chronic physical illness that impairs the general medical condition and a disease that will affect cognitive functions (neurological, neoplastic, endocrine and immune disorders, infection, epilepsy or any neurological disease, etc.).
- The patient has a physical illness (loss of limbs, paralysis, etc.) that requires additional care and causes significant disability
- Alcohol and substance use disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Physical Activity Level on Social Participation, Functioning and Quality of Life in Psychosis Patients
The aim of this study was to examine the effect of physical activity level on social participation, functioning and quality of life in patients with psychosis.
Read the detailed description
Positive and negative symptoms of schizophrenia will be assessed using the Positive and Negative Syndrome Scale, depression will be assessed using the Calgary Depression in Schizophrenia Scale, medication side effects will be assessed using the Glasgow Antipsychotic Side Effect Rating Scale, physical activity level will be assessed using the International Physical Activity Form, social participation will be assessed using the Social Participation Questionnaire, functioning will be assessed using the Brief Functioning Assessment Scale and quality of life will be assessed using the Nottingham Health Profile. The assessments are planned to last 30 minutes for each participant. Participants will be assessed only once and will not be reassessed.
- Conditions
- Psychosis
- Keywords
- Psychosis, Social Participation, Functioning, Quality of Life, Physical Activity
- Medical subject headings
- Psychotic Disorders, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Syndrome Scale
The scale is a 30-item semi-structured interview scale with a seven-point severity rating. In our study, individuals scoring below 70 points were included to confirm that the participants were not in the active disease period.
Measured: 6 months
Calgary Schizophrenia Depression Scale
The scale is an interviewer-rated scale and consists of 9 items in four-point Likert type. The cut-off score for schizophrenia accompanied by depressive disorder was determined as 11/12. In our study, individuals scoring below 11 points were included to confirm that the participants were not in a depressive episode.
Measured: 6 months
Glasgow Antipsychotic Side Effect Rating Scale
It is a 22-item self-report scale about the side effects of antipsychotics. An increase in the scale score indicates an increase in the severity of side effects
Measured: 6 months
International Physical Activity Form
This form consists of seven questions and provides information on sitting, walking, moderately vigorous activities and time spent in vigorous activities. The calculation of the total score of the short form includes the sum of duration (minutes) and frequency (days) of walking, moderately vigorous activity and vigorous activity. The sitting score (sedentary behavior level) is calculated separately. Physical activity levels are classified as physically inactive/inactive (<600 MET-min/week), physically inactive/minimally active (600-3000 MET-min/week) and physically active/very active (>3000 MET-min/week).
Measured: 6 months
Community Participation Survey
It is a method used to observe an individual's participation in the community. It consists of 15 headings. It is used to assess individuals' home, family life, social activities and work activities. Home activity is 10 points; social activity is 12 points and work activity is 7 points. The total score from 0 to 29 is calculated.
Measured: 6 months
Brief Functioning Assessment Scale
This scale, which will be used by the researchers, consists of questions designed to measure the extent to which patients experienced difficulties in autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relations, and leisure time activities during the study. The 24-item scale allows the measurement of 6 different domains of specific functioning: autonomy, occupational, cognitive, financial, interpersonal and leisure activities. The scale provides a total score as well as scores specific to sub-functioning domains. Items are scored according to their severity on a scale of 0 to 4. (0) = no difficulty, (1) = mild difficulty, (2) = moderate difficulty, (3) = severe difficulty. Scores on the scale can range from 0 to 72. A total score above 11 indicates a significant loss of functioning.
Measured: 6 months
Nottingham Health Profile
It is used to assess the quality of life of individuals. It consists of 2 parts. The first part includes six categories of energy, pain, physical mobility, sleep, emotional reactions and social isolation and consists of 38 different questions with yes or no answers. The second part consists of 7 questions. The questionnaire asks about current complaints. Positive answers to specific areas are used to assess severity or the sum of the six categories can be given as a profile. The total score for each of the 6 sub-parameters is between 0 and 100 and the total score for the total score is between 0 and 600. A high score indicates poor quality of life.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start20 Sep 2023
- Primary completion20 Mar 2024
- Study completion20 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandırma Onyedi Eylül University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazel Çelik Güzel, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408740
- Sponsor's protocol ID
- 2023-129
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physical Activity Level on Social Participation, Functioning and Quality of Life in Psychosis Patients
- ClinicalTrials.gov ID
- NCT06408740
- Acronym / sponsor ID
- 2023-129
- Conditions
- Psychosis
- Keywords
- Psychosis, Social Participation, Functioning, Quality of Life, Physical Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 20 Apr 2024 (actual)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to examine the effect of physical activity level on social participation, functioning and quality of life in patients with psychosis.
Detailed description
Positive and negative symptoms of schizophrenia will be assessed using the Positive and Negative Syndrome Scale, depression will be assessed using the Calgary Depression in Schizophrenia Scale, medication side effects will be assessed using the Glasgow Antipsychotic Side Effect Rating Scale, physical activity level will be assessed using the International Physical Activity Form, social participation will be assessed using the Social Participation Questionnaire, functioning will be assessed using the Brief Functioning Assessment Scale and quality of life will be assessed using the Nottingham Health Profile. The assessments are planned to last 30 minutes for each participant. Participants will be assessed only once and will not be reassessed.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Psychosis patients
Key inclusion criteria (4 listed)
- Patients diagnosed with schizophrenia and other psychotic disorders according to DSM-V criteria (brief psychosis disorder, schizophreniform disorder, schizoaffective disorder, other disorder with psychosis within the scope of another defined schizophrenia and other disorders with psychosis, other disorders with psychosis within the scope of undefined schizophrenia and other disorders with psychosis), who have had their first episode, who are receiving outpatient treatment
- Whose duration of illness is longer than 2 years
- Being between the ages of 18-65
- Being literate
Key exclusion criteria (5 listed)
- The participant is in a period of active illness that makes it difficult to conduct research (Positive and Negative Syndrome Scale>70 scale points, Calgary Depression in Schizophrenia Scale score >11 scale points)
- Comorbid psychiatric illness
- The patient has an acute or chronic physical illness that impairs the general medical condition and a disease that will affect cognitive functions (neurological, neoplastic, endocrine and immune disorders, infection, epilepsy or any neurological disease, etc.).
- The patient has a physical illness (loss of limbs, paralysis, etc.) that requires additional care and causes significant disability
- Alcohol and substance use disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Positive and Negative Syndrome Scale
Time frame: 6 months
The scale is a 30-item semi-structured interview scale with a seven-point severity rating. In our study, individuals scoring below 70 points were included to confirm that the participants were not in the active disease period.
Calgary Schizophrenia Depression Scale
Time frame: 6 months
The scale is an interviewer-rated scale and consists of 9 items in four-point Likert type. The cut-off score for schizophrenia accompanied by depressive disorder was determined as 11/12. In our study, individuals scoring below 11 points were included to confirm that the participants were not in a depressive episode.
Glasgow Antipsychotic Side Effect Rating Scale
Time frame: 6 months
It is a 22-item self-report scale about the side effects of antipsychotics. An increase in the scale score indicates an increase in the severity of side effects
International Physical Activity Form
Time frame: 6 months
This form consists of seven questions and provides information on sitting, walking, moderately vigorous activities and time spent in vigorous activities. The calculation of the total score of the short form includes the sum of duration (minutes) and frequency (days) of walking, moderately vigorous activity and vigorous activity. The sitting score (sedentary behavior level) is calculated separately. Physical activity levels are classified as physically inactive/inactive (<600 MET-min/week), physically inactive/minimally active (600-3000 MET-min/week) and physically active/very active (>3000 MET-min/week).
Community Participation Survey
Time frame: 6 months
It is a method used to observe an individual's participation in the community. It consists of 15 headings. It is used to assess individuals' home, family life, social activities and work activities. Home activity is 10 points; social activity is 12 points and work activity is 7 points. The total score from 0 to 29 is calculated.
Brief Functioning Assessment Scale
Time frame: 6 months
This scale, which will be used by the researchers, consists of questions designed to measure the extent to which patients experienced difficulties in autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relations, and leisure time activities during the study. The 24-item scale allows the measurement of 6 different domains of specific functioning: autonomy, occupational, cognitive, financial, interpersonal and leisure activities. The scale provides a total score as well as scores specific to sub-functioning domains. Items are scored according to their severity on a scale of 0 to 4. (0) = no difficulty, (1) = mild difficulty, (2) = moderate difficulty, (3) = severe difficulty. Scores on the scale can range from 0 to 72. A total score above 11 indicates a significant loss of functioning.
Nottingham Health Profile
Time frame: 6 months
It is used to assess the quality of life of individuals. It consists of 2 parts. The first part includes six categories of energy, pain, physical mobility, sleep, emotional reactions and social isolation and consists of 38 different questions with yes or no answers. The second part consists of 7 questions. The questionnaire asks about current complaints. Positive answers to specific areas are used to assess severity or the sum of the six categories can be given as a profile. The total score for each of the 6 sub-parameters is between 0 and 100 and the total score for the total score is between 0 and 600. A high score indicates poor quality of life.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychosis, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Syndrome Scale (time frame: 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.